search
Back to results

Treatment of Facial Burns With Flammacerium Compared to Flammazine and the Impact of Facial Burns on Psychosocial Wellbeing

Primary Purpose

Burns

Status
Completed
Phase
Phase 4
Locations
Netherlands
Study Type
Interventional
Intervention
ceriumnitrate silversulfadiazine (flammacerium)
silversulfadiazine (flammazine)
Sponsored by
Association of Dutch Burn Centres
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Burns focused on measuring facial burns, cerium flammazine, quality of life, randomised clinical trial

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: patients of 18 years of age or older, competent or temporarily incompetent, who are admitted to one of the three dedicated Dutch Burn Centres with burn injuries involving the face Exclusion Criteria: patients not seen within 24 hours postburn patients with mental or cognitive deficits that may interfere with providing informed consent patients with poor Dutch proficiency patients with chemical burns

Sites / Locations

  • Red Cross Hopsital, Burns Centre
  • Martini Hospital, Burns centre
  • Medical Centre Rijnmond South, Burns centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

'ceriumnitrate silversulfadiazine (flammacerium)

flammazine

Arm Description

facial burns treatment with Cerium nitrate silver sulfadiazine

facial burns treatment with silver sulfadiazine

Outcomes

Primary Outcome Measures

Regarding the efficacy of treatment
time to wound healing
* number of patients requiring surgical excision of their facial burns
number of patients requiring surgical treatment for healing of facial burns
Regarding psychosocial impact:
discrepancy between patient and observer scar assessment
* quality of life and self esteem
measurement of self esteem related to scar quality

Secondary Outcome Measures

● quality of scar (patient and observer)
scar assessment by patient and observer scar scale
● scar elasticity, vascularisation and pigmentation,
scar assessment by cutometer and dermaspectrometer
● hypertrophic surface area
scar thickness area
● functional and/or anatomic impairments,
descriptive analysis
● mimic function
physical examination

Full Information

First Posted
February 28, 2006
Last Updated
February 13, 2020
Sponsor
Association of Dutch Burn Centres
Collaborators
Dutch Burns Foundation
search

1. Study Identification

Unique Protocol Identification Number
NCT00297752
Brief Title
Treatment of Facial Burns With Flammacerium Compared to Flammazine and the Impact of Facial Burns on Psychosocial Wellbeing
Official Title
A Randomised Multicentre Clinical Trial on the Efficacy of Flammacerium in the Treatment of Facial Burns and the Impact of Facial Burns on Psychosocial Wellbeing
Study Type
Interventional

2. Study Status

Record Verification Date
August 2009
Overall Recruitment Status
Completed
Study Start Date
March 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Association of Dutch Burn Centres
Collaborators
Dutch Burns Foundation

4. Oversight

5. Study Description

Brief Summary
The face is involved in 40-50% of patients with burns admitted to the Dutch Burn Centres. Scarring of the face as a consequence of burns will often have a detrimental effect on function and aesthetics, and may cause negative effects on psychosocial wellbeing. What the best treatment is for facial burns, minimising scarring, is unclear. Besides that, there is little empirical evidence regarding the impact of facial scarring on psychosocial wellbeing. In clinical practice good results are felt to be achieved by treatment of facial burns with flammacerium. To substantiate the perceived advantages of flammacerium, its efficacy is compared to flammazine, a current alternative of care. The efficacy of treatment will be assessed in a prospective randomised multicentre clinical trial. Efficacy will be analysed in terms of number of patients requiring surgery and functional and aesthetic outcome. Apart from medical outcome, this study offers the opportunity to study psychosocial problems associated with facial defects. It is still an unresolved question whether facial scarring causes more or different psychosocial problems. Therefore, self-esteem and quality of life will be examined over time, in relation to depression, posttraumatic stress symptoms and other factors, such as coping style and social support. By evaluating the efficacy of different treatment strategies, we aim to optimise the standard of care of facial burns. Furthermore, this study wants to shed more light on the psychosocial impact of facial injury. With these results psychosocial professionals will be able to focus on persons at risk and to be better able to meet a patient's personal needs.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Burns
Keywords
facial burns, cerium flammazine, quality of life, randomised clinical trial

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
154 (Actual)

8. Arms, Groups, and Interventions

Arm Title
'ceriumnitrate silversulfadiazine (flammacerium)
Arm Type
Active Comparator
Arm Description
facial burns treatment with Cerium nitrate silver sulfadiazine
Arm Title
flammazine
Arm Type
Active Comparator
Arm Description
facial burns treatment with silver sulfadiazine
Intervention Type
Drug
Intervention Name(s)
ceriumnitrate silversulfadiazine (flammacerium)
Other Intervention Name(s)
CE-SSD
Intervention Description
treatment of patients with facial burns with CE-SSD
Intervention Type
Drug
Intervention Name(s)
silversulfadiazine (flammazine)
Other Intervention Name(s)
SSD
Intervention Description
treatment of patients with facial burns with SSD
Primary Outcome Measure Information:
Title
Regarding the efficacy of treatment
Description
time to wound healing
Time Frame
3 weeks
Title
* number of patients requiring surgical excision of their facial burns
Description
number of patients requiring surgical treatment for healing of facial burns
Time Frame
6 weeks
Title
Regarding psychosocial impact:
Description
discrepancy between patient and observer scar assessment
Time Frame
3 months
Title
* quality of life and self esteem
Description
measurement of self esteem related to scar quality
Time Frame
6 months post burn
Secondary Outcome Measure Information:
Title
● quality of scar (patient and observer)
Description
scar assessment by patient and observer scar scale
Time Frame
12 months post burn
Title
● scar elasticity, vascularisation and pigmentation,
Description
scar assessment by cutometer and dermaspectrometer
Time Frame
12 months post burn
Title
● hypertrophic surface area
Description
scar thickness area
Time Frame
12 months post burn
Title
● functional and/or anatomic impairments,
Description
descriptive analysis
Time Frame
12 months post burn
Title
● mimic function
Description
physical examination
Time Frame
12 months post burn

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: patients of 18 years of age or older, competent or temporarily incompetent, who are admitted to one of the three dedicated Dutch Burn Centres with burn injuries involving the face Exclusion Criteria: patients not seen within 24 hours postburn patients with mental or cognitive deficits that may interfere with providing informed consent patients with poor Dutch proficiency patients with chemical burns
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nancy van Loey, PhD
Organizational Affiliation
Association of Dutch Burns Centres
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Marianne K Nieuwenhuis, PhD
Organizational Affiliation
Association of Dutch Burn Centres
Official's Role
Principal Investigator
Facility Information:
Facility Name
Red Cross Hopsital, Burns Centre
City
Beverwijk
ZIP/Postal Code
1942 LE
Country
Netherlands
Facility Name
Martini Hospital, Burns centre
City
Groningen
ZIP/Postal Code
9728 NZ
Country
Netherlands
Facility Name
Medical Centre Rijnmond South, Burns centre
City
Rotterdam
ZIP/Postal Code
3075 EA
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
22842424
Citation
Oen IMMH, van Baar ME, Middelkoop E, Nieuwenhuis MK. Effectiveness of cerium nitrate-silver sulfadiazine in the treatment of facial burns: a multicenter, randomized, controlled trial. Plast Reconstr Surg. 2012 Aug;130(2):274e-283e. doi: 10.1097/PRS.0b013e3182589d63.
Results Reference
derived

Learn more about this trial

Treatment of Facial Burns With Flammacerium Compared to Flammazine and the Impact of Facial Burns on Psychosocial Wellbeing

We'll reach out to this number within 24 hrs